Asensus Surgical Robot Recalled by FDA Due to Uncontrolled Movement.
The Food and Drug Administration (FDA) recently classified a recall of the Asensus Surgical Senhance surgical robot as a Class I recall, indicating a high level of seriousness. Asensus initiated the recall after discovering that their Senhance system could malfunction, leading to unintended movements in the robotically assisted surgical device.
The malfunction manifested as uncontrollable rotation of the laparoscope instrument actuator (LIA). Specifically, the LIA was found to rotate incessantly in one direction once the surgeon disengaged the teleoperation mode on the system.
To address such incidents, the Senhance system was designed with an emergency stop feature. Fortunately, Asensus has reported no instances of patient harm or impact due to this malfunction so far. However, there is a potential risk of severe tissue damage due to this issue.
The recall impacts five devices in the U.S., identified by catalog numbers X9007708, X9007696, and X9007707, and distributed between April 13 and September 7, 2023. Asensus officially commenced the recall on September 15, 2023, as noted in an FDA announcement.
Customers with affected Senhance systems have been instructed to stop using them until an update to the device’s software, version 2.7.5, is implemented.
The Senhance system, approved by the FDA for general laparoscopic and gynecological laparoscopic procedures in 2017, has seen a range of expansions and collaborations since its introduction, including partnerships with Google and Nvidia and placements in hospitals across Japan, Germany, Switzerland, and Russia.
Notably, in March, the Senhance system was recognized as the first digital laparoscopic surgery system for pediatric use approved by the FDA. Among its advanced features, Senhance boasts the smallest 3 mm instruments in the surgical robotics field, which are reusable, a 5 mm camera scope, haptic feedback, eye-tracking camera control, 3D visualization, and the integration of machine learning and augmented reality for surgical assistance.
Asensus has also been developing a next-generation surgical robot, Luna, unveiled in February 2023. This new system promises advanced surgical capabilities and real-time intraoperative clinical intelligence. Recently, Asensus announced a partnership with Flex for Luna’s design and manufacturing services, aiming for FDA clearance by 2025.
How to File for Compensation
Patients who have experienced harm due to the malfunctioning Asensus Surgical Senhance surgical robot may have grounds to file a product liability lawsuit. Product liability lawsuits are legal actions taken against manufacturers, distributors, or sellers of products that cause injury due to defects or failure to warn about potential risks. In the case of the Senhance surgical robot, if patients suffered injuries due to the unintended movements of the device, they could seek legal recourse.
The process of filing a product liability lawsuit involves several key steps, and having an experienced attorney is crucial at each stage. Initially, the attorney helps in determining the viability of the case, which involves assessing the extent of injuries and linking them directly to the malfunctioning surgical robot. If a strong case is established, the attorney will then file a lawsuit on behalf of the victim.
During the lawsuit, the attorney plays a pivotal role in gathering evidence, including medical records, expert testimonies, and information about the device’s malfunction. They negotiate with the defendants and navigate through complex legal procedures, ensuring that the victim’s rights are upheld. A skilled attorney is also crucial during trial proceedings if the case goes to court.
Victims can seek various types of damages in a product liability lawsuit. These include compensatory damages for medical expenses, lost wages, and pain and suffering. In some cases, punitive damages may also be awarded, especially if the manufacturer’s negligence or recklessness is evident.
For individuals affected by the Asensus Surgical Senhance surgical robot malfunction, taking prompt legal action is vital. If you or a loved one has been a victim of this issue, contact Parker Waichman LLP, a national product injury law firm known for its success in handling complex product liability cases. Our firm offers a free consultation to help you understand your legal options and guide you through the process of seeking justice and compensation. You can contact them at 1-800-YOUR-LAWYER (1-800-968-7529) for more information and to discuss your case. Remember, taking legal action not only helps in recovering damages but also holds manufacturers accountable, contributing to safer medical practices in the future.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.
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